Let’s see if we can summarize the human experiments scandal.
I have an ongoing effort, along with many others to do battle with the EPA on air pollution research that violates scientific rules on how to prove causation.
Milloy and I found out the EPA was doing human experiments under the radar exposing subjects to what EPA said was lethal and toxic, even carcinogenic air pollution.
Here’s where we are in 2014:
Either the EPA is sponsoring horrific human experiments, or they are lying to the Congress about the toxicity of air pollution.
A REVIEW of HUMAN EXPERIMENTATION By the EPA.
Here’s the Journal article we wrote on EPA’s human experiments.
Environmental Protection Agency’s
Air Pollution Research: Unethical and Illegal?
Steve Milloy, M.H.S., J.D., L.L.M.
John Dale Dunn, M.D., J.D.
1. Lisa Jackson said fine particles kill hundreds of thousands, and that’s a big risk not a small one.
EPA Administrator Lisa Jackson testified before Congress in September 2011: “Particulate matter causes premature death. It
doesn’t make you sick. It’s directly causal to dying sooner than you should.”She added, “If we could reduce particulate matter to
levels that are healthy we would have an identical impact to finding a cure for cancer.” (Cancer kills about 570,000 in the U.S.
annually, according to the American Cancer Society).
2. Jon Samet, MD Chair of the Clean Air Scientific Advisory Committee to the US EPA wrote there is no safe level of small particle air pollution. Samet’s view was repeatedly echoed by USEPA air chief Gina McCarthy in a February 2012 letter to House Energy and Commerce Chairman Fred Upton(R-Mich.).
3. Senior research scientist at U of North Carolina School of Medicine, on the EPA Human experimentation project, Robert Devlin PhD, said that the epidemiology was not enough to prove their case so they have been doing Human Experiments for more than a 2 decades.
No breakthroughs have occurred so the EPA still relies on its admittedly weak epidemiological studies.
Devlin himself has claimed to do more than 50 human exposure experiments in his declaration under oath. And he details the inadequacy of epidemiology to prove up the EPA claim about lethality, which is why he justifies human exposure experiments.
In his declaration Devlin admitted the EPA’s epidemiology was inadequate to prove toxicity or lethality.
7. Epidemiological observations are the primary tool in the discovery of risks to public health such as that presented by ambient PM2.5. However, epidemiological studies do not generally provide direct evidence of causation. They indicate the existence or lack of a statistical relationship between ambient levels of PM2.5 and adverse health outcomes. Large population studies cannot assess the biological mechanisms (called biological plausibility) that could
explain how inhaling ambient air pollution particles can cause illness or death in susceptible individuals. This sometimes leaves open the question of whether the observed association in the epidemiological study is causal or whether PM2.5 is merely a marker for some other unknown substance.
8. Controlled human exposure studies conducted by EPA scientists and EPA funded scientists at multiple universities in the United States fill an information gap that cannot be filled by large population studies.
4. If the testimony in Congress by Ms. Jackson and the opinion of Jon Samet are sincerely held they are committing a criminal unethical and immoral act by exposing unknowing individuals to lethal. harmful or carcinogenic air pollutants in violation of American and International Law.
The Common Rule was adopted by the EPA to govern human experiments:
Criteria for Institutional Review Board (IRB) Approval of Research. Risks to human subjects must be minimized and not unnecessary. Risks must be reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result.
Informed consent must be sought documented from each subject. [40 CFR 26.111]
Suspension or termination of IRB approval of research. An IRB shall have authority to suspend or terminate approval of research that is associated with unexpected serious harm to subjects. [40 CFR 26.113]
Informed Consent. Subjects must be informed of the reasonably foreseeable risks or discomforts of the experiment and any reasonably expected benefits. [40 CFR 26.116]
The EPA expanded on the Common Rule with
EPA Order 1000.17
EPA began implementing the principles of the Belmont Report in 1977 through EPA Order 1000.17, which was subsequently modified in 1999 and 2011 through EPA Order 1000.17 Change A1.
As the EPA experiments in question commenced after 1999 but before the 2011 changes to EPA Order 1000.17, we will focus on the 1999 version of the Order.
Summarized below are the EPA Order 1000.17 provisions that are most relevant to the subject of this website.
“Research” means a “systematic” investigation contributing to “generalizable knowledge.” [Section 3.a]
“Material non-compliance means failure to comply with the Common Rule and [EPA Order 1000.17] necessary to carry out their essential policies of protecting human subjects of research from anything more than minimal risk.” [Section 3.e]
“Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life…” [Section 3.f]
“Risk of substantial injury means a significant probability that the research may lead to a substantial impairment of normal activities or long-lasting or irreversible damage to the health of a human being.” [Section 3.g]
There is a presumption that studies involving risk of substantial injury to a human subject from the conduct of a study and that studies testing for the irreversible health effects in humans will not be approved… unless strongly persuasive additional justification acceptable to the Review Official is submitted.” [Section 4.c]
“To obtain the approval of the Review Official, submitted documents must include… written approval from each institution’s IRB…” [Section 5.b]
“The Review Official has the authority to have any study suspended or terminated… (iii) if there is good reason to believe that the rights and welfare of human research subjects are not being adequately protected, or (iv) if there has been unexpected serious harm to one or more human subjects.” [Section 6.a(4)]
Any EPA employee who has knowledge that EPA supported or conducted research has been associated with unexpected serious harm to one or more human subjects shall immediately notify the Review Official.” [Section 6.e]
Common Law proscriptions in American Law as discussed in
The Reference Manual on Scientific Evidence published by the Federal Judicial Center.
This Federal Judicial Center publication was undertaken in furtherance of the Center’s statutory mission to develop and conduct education programs for judicial branch employees. The views expressed are those of the authors and not necessarily those of the
Federal Judicial Center.
An electronic version of the Reference Manual can be downloaded from the
Federal Judicial Center’s site on the World Wide Web. Go to
http://air.f jc.gov/public/f jcweb.nsf/pages/16
The Authors of the Chapter on Epidemiology, including Leon Gordis MD Dr PH an icon, write
at p 339 in the Chapter on Epidemiology
Footnote 14. Experimental studies in which human beings are exposed to agents known or thought to be
toxic are ethically proscribed. See Ethyl Corp. v. United States Envtl. Protection Agency, 541 F.2d 1,
26 (D.C. Cir.), cert. denied, 426 U.S. 941 (1976).
The Nuremberg Code (which was adopted in toto by California) prohibits harmful, certainly lethal, human experiments except exceptions and emphasizes the importance of freely given consent.
There are two California Medical Schools performing human experimentation exposing subjects to small particle air pollution—USC and UCLA. See the declaration by Eugene Cascio that names UNC, Rutgers, Rochester, Ohio State, MI, Mich State, Washington, USC, UCLA and Lovelace of New Mexico.
The ten points of the Nuremberg Code
The 10 points are:
1 The voluntary consent of the human subject is absolutely essential. This means that the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, over-reaching, or other ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable him/her to make an understanding and enlightened decision. This latter element requires that before the acceptance of an affirmative decision by the experimental subject there should be made known to him the nature, duration, and purpose of the experiment; the method and means by which it is to be conducted; all inconveniences and hazards reasonable to be expected; and the effects upon his health or person which may possibly come from his participation in the experiment. The duty and responsibility for ascertaining the quality of the consent rests upon each individual who initiates, directs or engages in the experiment. It is a personal duty and responsibility which may not be delegated to another with impunity.
2 The experiment should be such as to yield fruitful results for the good of society, unprocurable by other methods or means of study, and not random and unnecessary in nature.
3 The experiment should be so designed and based on the results of animal experimentation and a knowledge of the natural history of the disease or other problem under study that the anticipated results will justify the performance of the experiment.
4 The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury.
5 No experiment should be conducted where there is a prior reason to believe that death or disabling injury will occur; except, perhaps, in those experiments where the experimental physicians also serve as subjects.
6 The degree of risk to be taken should never exceed that determined by the humanitarian importance of the problem to be solved by the experiment.
7 Proper preparations should be made and adequate facilities provided to protect the experimental subject against even remote possibilities of injury, disability, or death.
8The experiment should be conducted only by scientifically qualified persons. The highest degree of skill and care should be required through all stages of the experiment of those who conduct or engage in the experiment.
9 During the course of the experiment the human subject should be at liberty to bring the experiment to an end if he has reached the physical or mental state where continuation of the experiment seems to him to be impossible.
10 During the course of the experiment the scientist in charge must be prepared to terminate the experiment at any stage, if he has probable cause to believe, in the exercise of the good faith, superior skill and careful judgment required of him that a continuation of the experiment is likely to result in injury, disability, or death to the experimental subject.
Reprinted from Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10, Vol. 2, pp. 181–182. Washington, D.C.: U.S. Government Printing Office, 1949.
The Helsinki Declarations prioritize the welfare of the subject and the necessity for informed consent.
The Belmont Report, is influential in ethical studies on human experiments, and was published in the Federal Register in 1979. The Report was created by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Its full title is the Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research, Report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.
Belmont emphasizes respect, beneficence, and justice and the importance of informed consent, assessment of risks and benefits, and selection of subjects.
Would the EPA object to the content and intent of the Ethical advisories described above?
Either the EPA is lying about the toxicity of small particle air pollution which is a fraud on the citizens and misconduct in a position of trust.
The EPA is funding and sponsoring and Medical Schools are complicit in unethical and immoral/illegal human experiments.
What’ll it be?